Integration of infusion pump with remote electronic device

ABSTRACT

A system and method can provide for a remote electronic device to be used to remotely initiate delivery of a medicament bolus with a medical device, such as an insulin pump, with the medical device providing audible or tactile confirmation of the programmed bolus. The bolus amount can be calculated by or programmed or otherwise entered into the smartphone, etc., and then transmitted to the medical device. When the pump receives the transmitted bolus amount, it issues one or more indications such as audible sounds and/or vibrations in any number of desired combinations. For instance, each individual sound or vibration may correspond to an increment of the medicament. The user can therefore determine the size of the medicament bolus by the number of sounds or vibrations and can confirm or cancel delivery of the bolus.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 15/653,723filed Jul. 19, 2017, which in turn is a continuation of application Ser.No. 14/583,274 filed Dec. 26, 2014, now U.S. Pat. No. 9,737,656 issuedAug. 22, 2017, which claims the benefit of U.S. Provisional ApplicationNo. 61/920,932 filed Dec. 26, 2013, U.S. Provisional Application No.61/920,914 filed Dec. 26, 2013, and U.S. Provisional Application No.61/920,902 filed Dec. 26, 2013, each of which is incorporated herein inits entirety by reference.

FIELD OF THE INVENTION

The present invention relates to wireless control of and/orcommunication with drug delivery devices.

BACKGROUND

There are many applications in academic, industrial, and medical fieldsthat benefit from devices and methods that are capable of accurately andcontrollably delivering fluids, such as liquids and gases, that have abeneficial effect when administered in known and controlled quantities.Such devices and methods can be particularly useful in the medical fieldwhere treatments for many patients include the administration of a knownamount of a substance at predetermined intervals.

One category of devices for delivering such fluids is that ofinsulin-injecting pumps that have been developed for the administrationof insulin for those suffering from both type I and type II diabetes.Some insulin injecting pumps configured as portable infusion devices canprovide continuous subcutaneous insulin injection and/or infusiontherapy for the treatment of diabetes. Such therapy may include theregular and/or continuous injection or infusion of insulin into the skinof a person suffering from diabetes and offer an alternative to multipledaily injections of insulin by an insulin syringe or an insulin pen.Such pumps can be ambulatory/portable infusion pumps that are worn bythe user and may use replaceable cartridges. Examples of such pumps andvarious features that can be associated with such pumps include thosedisclosed in U.S. patent application Ser. No. 13/557,163, U.S. patentapplication Ser. No. 12/714,299, U.S. patent application Ser. No.12/538,018, U.S. patent application Ser. No. 13/838,617, U.S. patentapplication Ser. No. 13/827,707 and U.S. Pat. No. 8,287,495, each ofwhich is hereby incorporated herein by reference in its entirety.

With the proliferation of handheld electronic devices, such as mobilephones (e.g., smartphones), there is a desire to be able to remotelyutilize such devices to optimize usage of infusion pump devices.

Infusion pumps are often discretely located on or around a patient, suchas beneath clothing or in a carrying pouch. Some infusion pumps aretherefore adapted to be programmed and/or controlled with remote devicesthat enable programming and/or control without directly interacting witha user interface of the pump. These remote controllers therefore enablea pump to be programmed and/or operated more privately and comfortably.Accordingly, one potential use of such handheld consumer electronicdevices, such as smartphones, tablets and the like, is to utilize suchdevices as a controller for remotely programming and/or operating aninfusion pump. However, without viewing the pump there would be no wayto determine whether the pump is, e.g., receiving commands from thesmartphone, has been properly programmed by the smartphone, etc., andtherefore the risk of improper medicament delivery could exist.

Many infusion pumps design to delivery insulin to a patient are capableof integrating with diabetes management software run on a computer. Suchsoftware typically provides a convenient and visual way to display datafrom the pump and associated devices, such as blood glucose meters. Useof such systems enables patients and caregivers to easily track andanalyze treatment data and trends to optimize diabetes therapy. However,in many cases, data must be transferred from the pump directly to acomputer running the management software by a wired connection or with aportable memory device such as a flash drive. Inconveniences posed bysuch requirements can lead to data not being timely or properly or evertransferred to the management software, which in turn leads to under orimproper utilization of the software or in some cases the software notbeing used at all.

In addition, the typical age of diagnosis of type I diabetes is 14 yearsold or younger. Thus, a significant percentage of the people thatutilize insulin pumps are children who may spend their time in, e.g.,daycare facilities, school, or other locations away from parents orprimary caregivers. Generally, children below a certain age are notgiven the responsibility of monitoring their blood sugar levels and/ordosing insulin themselves, and therefore when those children are atschool they must obtain the assistance of an adult such as the schoolnurse, teacher, etc., each time insulin needs to be dosed. Thisfrequently presents an inconvenience to both the child as well as toschool officials, and even the child's peers, not to mentionembarrassment for the child patient and disruption of the child'seducational experience. It would therefore be desirable for children tosafely play a larger role in the management of their disease byproviding a way for them to initiate dosing of insulin and/or othermedicaments themselves, while still providing some level of oversightfrom an adult, without the child having to personally visit a schoolnurse or other authorized caregiver.

SUMMARY OF THE INVENTION

Systems and methods according to embodiments of the present inventionprovide for use of devices such as a mobile telephone (sometimesreferred to as a cellular telephone), such as a smartphone, or othercomputing device such as a tablet, laptop computer, personal computer,etc. to remotely program, control and/or communicate with an infusionpump.

A system and method can provide for a remote electronic device to beused to remotely initiate delivery of a medicament bolus with a medicaldevice, such as an insulin pump, with the medical device providingaudible or tactile confirmation of the programmed bolus. The bolusamount can be calculated by or programmed or otherwise entered into thesmartphone, etc., and then transmitted to the medical device. When thepump receives the transmitted bolus amount, it issues one or moreindications such as audible sounds and/or vibrations in any number ofdesired combinations. For instance, each individual sound or vibrationmay correspond to an increment of the medicament. The user can thereforedetermine the size of the medicament bolus by the number of sounds orvibrations and can confirm or cancel delivery of the bolus.

In one such embodiment, a smartphone communicates with an insulin pumpto facilitate delivery and confirmation of an insulin bolus to a patientwith the pump. The smartphone can include a software application and/orfirmware that permit programming and/or calculation of an insulin bolusand transmission of a bolus command or communication to the pump. Thepump receives the bolus command and provides audible and/or tactilefeedback to the user indicating the size of the bolus. For example, eachsound or vibration may, for example, correspond to 0.5 units of insulinto be delivered. Thus, if the pump provides ten beeps or vibrations, theuser knows the pump is intending to deliver a bolus of five units ofinsulin based on the received command. If this is an expected and/oracceptable amount, the user can confirm the delivery to permit the pumpto deliver the bolus.

A system and method can also provide for remote authorization ofdelivery of a medicament with a medical device, such as, an infusionpump is described. A caregiver device controlled by a parent or othercaregiver, such as a smartphone, can be in wireless communication with apatient being treated with a medical device, such as a minor child.Information pertaining to a requested operation to be performed by themedical device can be transmitted from the medical device to thecaregiver device. The caregiver can review information pertaining to therequest on the caregiver device to determine if the operation should beperformed. If the caregiver authorizes the operation, a confirmation canbe send to the medical device and the operation is then performed.

In one such embodiment, a system for remote authorization of delivery ofa medicament includes a caregiver device, such as a mobile phone (e.g.,a smartphone), and a medical device, such as an insulin pump, inwireless communication with each other. A request for delivery ofinsulin with the insulin pump, such as delivery of a meal bolus, can besent from the insulin pump to the caregiver smartphone. The caregivercan review the request and corresponding information and, ifappropriate, authorize the request. Once the request is authorized, theinsulin pump can proceed with delivery of the requested amount ofinsulin, either automatically or upon receiving patient confirmation.

In another such embodiment, a method for remotely authorizing deliveryof a medicament by a medical device, such as an insulin pump, includesreceiving a request for insulin delivery from the infusion pump at acaregiver device, such as a smartphone. The request as well ascorresponding information, such as, for example, blood glucose level andinsulin on board, can be reviewed on the caregiver device. Authorizationto deliver insulin can be provided by the caregiver through thesmartphone and transmitted to the insulin pump. The pump can thenproceed with delivery of the requested amount of insulin.

A system and method can further provide for use of a mobile phone, suchas a smartphone, to aid in determining, programming and data trackingtherapy provided by a medical device such as an insulin pump. Asmartphone can be in wireless communication with an insulin pump and canalso be capable of connecting to one or more additional devices, such asa blood glucose meter or a therapy management system. The smartphone canfacilitate the transfer of data and measurements between and among thesedevices.

In one such embodiment, a smartphone communicates with an insulin pumpand a blood glucose meter. The smartphone can connect to the bloodglucose meter to receive a current or recent blood glucose value andthen transmit that value to the insulin pump. The pump can then use thatrecent value to determine whether a bolus is needed. A communication canthen be sent to the phone to confirm to the user whether a bolus is oris not needed, and the user can refer to the pump to deliver a neededbolus.

In another such embodiment, a smartphone communicates with a therapymanagement system to enhance data logging relating to treatment with aninsulin pump. Features of the smartphone such as the camera or speakercan obtain files, such as images or voice recordings, containinginformation on meals to be consumed by the user. These files can betransmitted to the therapy management system for incorporation into thedata analysis of the system and correlated with therapy delivered by thepump that is also tracked by the system.

Certain embodiments are described further in the following description,examples, claims, and drawings. These embodiments will become moreapparent from the following detailed description when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a medical device that can be utilized with embodiments of thepresent invention.

FIG. 2 is a block diagram representing a medical device that can be usedwith embodiments of the present invention.

FIG. 3 depicts a medical device such as an insulin infusion pump thatcan be used with embodiments of the present invention displaying on auser interface an exemplary screen shot of a home page of the userinterface.

FIG. 4A is an exemplary screen shot of a “quick bolus” page of a userinterface of a medical device such as an infusion pump according to anembodiment of the present invention.

FIG. 4B is an exemplary screen shot of a “quick bolus” page of a userinterface of a medical device such as an infusion pump according to anembodiment of the present invention.

FIG. 4C is an exemplary screen shot of a “quick bolus” page of a userinterface of a medical device such as an infusion pump according to anembodiment of the present invention.

FIG. 4D is an exemplary screen shot of a “quick bolus” page of a userinterface of a medical device such as an infusion pump according to anembodiment of the present invention.

FIG. 5 is schematic representation of a system for facilitatingprogramming of a medical device according to embodiments of the presentinvention.

FIG. 6 is a flowchart of steps for using a mobile phone to aid inadministering therapy with a medical device according to embodiments ofthe present invention.

FIG. 7 is schematic representation of a system for remotely authorizingdelivery of a medicament according to embodiments of the presentinvention.

FIG. 8 is a flowchart of a method of remotely authorizing delivery of amedicament according to embodiments of the present invention.

FIG. 9 is schematic representation of a system for facilitatingprogramming of a medical device according to embodiments of the presentinvention.

FIG. 10 is a flowchart of steps for using a mobile phone to aid inadministering therapy with a medical device according to embodiments ofthe present invention.

FIG. 11 is a schematic representation of a system for using a mobilephone to facilitate data logging of use of a medical device according toembodiments of the present invention.

DETAILED DESCRIPTION

FIG. 1 depicts an embodiment of a medical device that can be used withembodiments of the present invention. In this embodiment, the medicaldevice is configured as a pump 12 such as an infusion pump that caninclude a pumping or delivery mechanism and reservoir for deliveringmedicament to a patient and an output/display 44. The type ofoutput/display 44 may vary as may be useful for a particularapplication. The type of visual output/display may include LCD displays,LED displays, plasma displays, graphene-based displays, OLED displaysand the like. The output/display 44 may also be an interactive or touchsensitive screen 46 having an input device such as, for example, a touchscreen comprising a capacitive screen or a resistive screen. The pump 12may additionally include a keyboard or other input device known in theart for data entry, which may be separate from the display. The pump 12may also include a capability to operatively couple to a secondarydisplay device such as a remote display, a remote control device, alaptop computer, personal computer, tablet computer, mobilecommunication device such as a smartphone or personal digital assistant(PDA) or the like. In other embodiments, the pump 12 may not include adisplay.

In one embodiment, medical device can be a portable insulin pumpconfigured to deliver insulin to a patient. Further details regardingsuch pump devices can be found in U.S. Pat. No. 8,641,671, which isincorporated herein by reference in its entirety. In other embodiments,medical device can be an infusion pump configured to deliver one or moreadditional or other medicaments to a patient. In a further embodiment,the medical device can be a glucose meter such as a continuous glucosemonitor. Further detail regarding such systems and definitions ofrelated terms can be found in, e.g., U.S. Pat. Nos. 8,311,749, 7,711,402and 7,497,827, each of which is hereby incorporated by reference hereinin its entirety. In other embodiments, the medical device can monitorother physiological parameters of a patient.

FIG. 2 illustrates a block diagram of some of the features that may beincorporated within the housing 26 of a medical device such as a pump 12that can be used with embodiments of the present invention. The pump 12can include a processor 42 that controls the overall functions of thedevice. The infusion pump 12 may also include a memory device 30, atransmitter/receiver 32, an alarm 34, a speaker 36, a clock/timer 38, aninput device 40, a user interface suitable for accepting input andcommands from a user such as a caregiver or patient, a drive mechanism48, and an estimator device 52. One embodiment of a user interface asshown in FIG. 2 is a graphical user interface (GUI) 60 having a touchsensitive screen 46 with input capability. In some embodiments, theprocessor 42 may communicate with one or more other processors withinthe pump 12 and/or one or more processors of other devices; for example,a continuous glucose monitor (CGM), display device, smartphone, etc.through the transmitter/receiver. The processor 42 may also includeprogramming that may allow the processor to receive signals and/or otherdata from an input device, such as a sensor that may sense pressure,temperature or other parameters. In some embodiments, the processor 42can communicate with a safety processor as disclosed in U.S. patentapplication Ser. No. 14/581,461, entitled Safety Processor for WirelessControl of a Drug Delivery Device, which is hereby incorporated byreference herein in its entirety.

Referring to FIG. 3, a front view of a pump 12 is depicted. Pump 12 mayinclude a user interface, such as, for example, a GUI 60 on a frontsurface 58 or other location of pump 12. GUI 60 may include atouch-sensitive screen 46 that may be configured for displaying data,facilitating data and/or command entry, providing visual tutorials, aswell as other interface features that may be useful to a caregiver or tothe patient operating pump 12. The GUI can also present alarms or alertsto the user.

In some embodiments, pump 12 can be used to deliver a “quick” or “audio”bolus of medicament. A quick bolus enables programming of a bolus usinga single button with the pump confirming the configuration of the boluswith audible sounds, vibrations, visual indications or combinationsthereof. Depictions of various quick bolus delivery configuration pages62 that can be displayed on the graphical user interface 60 of a pump 12are depicted in FIGS. 4A-4D.

When a quick bolus option is activated or selected, a quick bolusdelivery configuration page 64, such as shown in FIG. 4A, can bedisplayed on the user interface. The quick bolus delivery configurationpage 64 asks the user to press a quick bolus button (which can be, forexample, a physical button or switch on pump 12 or a touch-selectableportion of the user interface 60) one or more times to increase the sizeof a desired bolus. The bolus size can be increased, for example, basedon a fixed number of carbohydrates associated with each button pressand/or by a fixed number of units of insulin corresponding to eachbutton press. Each time the user presses the bolus button, for example,the grams of carbohydrates and units of insulin displayed on the quickbolus delivery configuration page increases. For example, as shown inFIG. 4B, if the pump has stored a predefined value of five grams ofcarbohydrates for each button press, after the user has pressed thebutton three times the configuration page 64 can indicate that a bolusof 1.5 units of insulin corresponding to, in this example, 15 grams ofcarbohydrates will be delivered. The conversion between carbohydratesand units of insulin can be based on known and/or stored carbohydrateratios for the user. The user can cancel the quick bolus delivery at anytime by selecting a cancel button 66.

Once the quick bolus has been programmed, either by the user indicatingthat the bolus programming is complete or by a predetermined period oftime passing since the last button press, the pump notifies the uservia, for example, audible and/or vibratory sounds that the bolus hasbeen initiated. In some embodiments, a countdown notification 68 asshown in FIG. 4C can be shown on the user interface counting down todelivery of the bolus. Once the bolus delivery has been started, anotification 70 that the bolus has been started can also be presented onthe user interface as shown in FIG. 4D.

The sounds or vibration notifying the user of the initiation of thebolus can also serve as a confirmation of the size of the bolus in someembodiments. This is convenient when a user is programming the boluswithout looking at the user interface, such as when the user isdiscretely programming a bolus on a pump located under the user'sclothing. For example, the pump can issue a series of vibrations, beepsor other sounds, with each sound corresponding to a predeterminedincrement of the quick bolus. A user therefore needs only to determinethat the number of beeps and/or vibrations, etc., corresponds with thesize of the bolus intended to be delivered, and then allow the pump todeliver the bolus without having to visually review the informationpresented on the GUI regarding the quick bolus. In some embodiments, thepump can also provide specific audible and/or vibratory feedback toindicate additional actions pertaining to programming of the quickbolus, such as, for example, two beeps and/or vibrations upon initiationof the quick bolus program, a beep and/or vibration as each increment isadded to the quick bolus and one or more beeps and/or vibrations toindicate that the bolus delivery has been initiated. Further detailsregarding delivery of quick or audio boluses that can be delivered withpumps 12 of the present invention are disclosed in U.S. Pat. Nos.8,287,495 and 8,346,399, which are hereby incorporated by referenceherein. Alone or in combination with various ways to provide commandinput and/or receiving feedback regarding the quick bolus, naturallanguage voice input from a user with, for example, natural languagevoice confirmation from the pump via a speaker, can be used in all ofthe embodiments described herein.

Referring now to FIG. 5, a system 100 according to embodiments of thepresent invention includes a medical device such as an insulin pump 12having a wireless connection 104 to a mobile phone 102, such as asmartphone, via, for example, Bluetooth®, Bluetooth® low energy, mobile,Wi-Fi or other communications protocols and modalities. Although thesystem 100 is described with respect to a mobile phone, alternate typesof remote consumer electronic devices could be used in place of a phoneas the device 102, including, for example, an electronic tablet or alaptop or desktop computer. A remote consumer electronic device as usedherein refers to devices having their own processor, memory, etc. thatare useable for a variety of functions, such as, for example, phonecalls, emails and accessing the internet, beyond simply being a remotecontrol device for a medical device. In other embodiments of each of thesystems and methods described throughout this disclosure, however, aremote device used with the present invention can be a dedicated remotecontrol device. Similarly, although described with respect to an insulinpump, the medical device 12 can be any other type of programmablemedical device capable of wirelessly communication with a mobile phone12 or other device, including, for example, infusion pumps for infusingmedicaments in addition to or other than insulin.

In some embodiments, the smartphone 102 of the system of FIG. 5 can beused to program a bolus delivery by insulin pump 12, with notificationand confirmation of the bolus provided by the pump in any manner similarto those of the quick bolus feature of the pump described above.Referring to FIG. 6, a method of initiating delivery of a bolus 200 witha mobile phone such as a smartphone begins with a smartphone that iswirelessly or otherwise operatively connected to an insulin pumpdisplaying status items relating to the pump on the phone at step 202.When a bolus delivery is desired, the smartphone can calculate the bolusat step 204 taking into account parameters known through the pump suchas, for example, insulin on board and blood glucose level as well as anumber of carbohydrates the user is expected to consume. The bolusrequest is then sent from the smartphone to the pump at step 206 toinitiate delivery of the bolus. After the pump receives the bolusrequest, the pump provides an auditory and/or vibratory notificationrelating to the bolus at step 208. For example, as with the quick bolusdelivery methods described above, the pump can issue one beep and/orvibration for each predefined bolus increment to indicate a size of thebolus. At step 210, the pump delivers the bolus, either after aconfirmation by the user or automatically after no user action during apredetermined period of time. In some embodiments, the confirmation ismade by the user at the pump. In other embodiments, the user confirmsdelivery on the smartphone. In still other embodiments, the confirmationmay be made on either the pump or the smartphone.

For example, if a user is going to eat a meal, the user can enter thenumber of carbohydrates that are going to be consumed into thesmartphone and the phone can calculate a bolus based on the number ofcarbohydrates, insulin to carbohydrate ratio, insulin on board andcurrent blood glucose level, for example. The calculated value, forexample five units of insulin, is shown on the phone display orotherwise communicated to the user. The user can then execute a commandon the phone to send the bolus to the pump. In some embodiments, thesmartphone can have a software application thereon that facilitates thecalculations and communicates with the pump. When the pump receives thecommand or other communication, the command from the smartphone causesit to provide confirmatory feedback as described herein, such as byplaying an auditory and/or vibratory sequence representing the bolus,e.g., a series of five beeps representing each of the five units ofinsulin. If the auditory or vibratory sequence comports with the user'sexpectations, the user can confirm the delivery, such as by pressing abutton on the pump, and the pump delivers the bolus as a result of theoperating command from the smartphone. In other embodiments, the boluscan be automatically delivered a predetermined period of time after thesequence if the bolus is not cancelled. In some embodiments, feedbackthat can be the same as or different from that described above can alsobe provided at the smartphone or other device from which the bolus orother command is sent. In various embodiments, boluses can be calculatedwith the smartphone based on other parameters relating to treatment of apatient. For example, the smartphone could receive information relatingto a blood glucose level of a patient, such as, for example, informationfrom a continuous glucose monitor or blood glucose meter, and utilizethat data to calculate a bolus.

In some embodiments, system 100 can be used to deliver extended boluses,e.g., boluses delivered slowly over a set extended period of time andsplit boluses, which are boluses in which a portion of the insulin isdelivered immediately and a portion is delivered over an extendedperiod. Further details regarding such boluses can be found in U.S. Pat.No. 6,852,104, which is hereby incorporated by reference in itsentirety. In such embodiments, an extended bolus or an extended portionof a bolus can have a different auditory and/or vibratory indicator,such as, for example, a different tone, different key, differentharmonic, different sound length, etc. than boluses or portions ofboluses that are delivered as fast as possible. For example, if a bolusis programmed with the smartphone and sent to the pump that includesdelivering two units of insulin immediately and three units of insulinover the next hour, the pump can issue two identical sounds orvibrations representing the two units of insulin to be deliveredimmediately followed by three identical sounds or vibrations that aredifferent from the first two sounds or vibrations, with the final threesounds or vibrations representing the three units of insulin to bedelivered over the extended period. In some embodiments, the pump canalso use sounds or vibrations to indicate the amount of time over whichan extended bolus or portion of a bolus is delivered. For example,additional sounds or vibrations can be issued with each indicating apredetermined increment of time, such as a half hour, or extendedboluses delivered over different periods of time can each be indicatedwith distinct size increment sounds. Visual and/or natural languageindications as described herein may also be used alone or in combinationwith sound and/or vibratory feedback techniques for delivery of extendedand split boluses.

Referring now to FIG. 7, a schematic representation of a system 300 forremote authorization of delivery of a medicament is depicted. System 300includes a medical device, such as, for example, an insulin pump in afirst location 304. System 300 also includes a caregiver device 302.Typically, caregiver device 302 will be in a location 306 remote fromthe location 304 of the medical device 12. A location 306 remote fromthe location 304 of the medical device 12 could include, for example,anywhere between a place hundreds of miles from the medical device to alocation in the same room as the medical device 12. Communicationbetween caregiver device 302 and medical device 12 therefore may beperformed done wirelessly via, for example, Bluetooth®, Bluetooth® lowenergy, mobile, Wi-Fi or other communications protocols and modalities.In some embodiments, caregiver device 302 is a mobile phone, such assmartphone. Alternatively, caregiver device 302 can be any other type ofdevice capable of wired or wireless communication with medical device 12such as, for example, an electronic tablet or a laptop or desktopcomputer.

FIG. 8 depicts a flowchart of a method 310 of remotely authorizingdelivery of a medicament according to an embodiment of the presentinvention. At step 312, the medical device sends a request through awireless connection to the caregiver device. The request can includedetails pertaining to deliver of a medicament with the medical device,such as a number of units of insulin requested for a bolus. The requestcan also include additional information to aid the caregiver indetermining whether the request is appropriate. In the case of aninsulin bolus, for example, the request can include a current or recentblood glucose level, a number of carbohydrates and/or other nutritionalinformation pertaining to a meal about to be or recently consumed and/orthe amount of unmetabolized insulin left in the patient's system, orinsulin on board (IOB). In one embodiment, the information can include apicture of a meal about to be consumed by the patient for review by aparent or caregiver overseeing a child patient that may have difficultycounting the carbohydrates in a meal. In some embodiments, the requestcan be entered into a user interface of the medical device by thepatient. Alternatively, the medical device can automatically determinethat an operation should be carried out based on available data such as,for example, blood glucose level of the patient. In such an embodiment,the request can be automatically transmitted to the caregiver device oran alert can appear on the user interface requiring patient confirmationto transmit the request. At step 314, the request and associatedinformation can be displayed on the caregiver device for review by thecaregiver.

If the caregiver determines after review of the request and associatedinformation that the requested operation should be carried out, thecaregiver provides authorization through the caregiver device that istransmitted wireless to the remotely located medical device at step 316.An alert can appear on a user interface of the medical pump that therequest has been authorized. In some embodiments, the patient can berequired to confirm the request to initiate the operation.Alternatively, the operation can be automatically carried out afterbeing authorized by the caregiver. After receiving final authorizationfrom the caregiver device and/or through its own user interface, themedical device carries out the requested operation at step 318. If thecaregiver determines that the requested operation should not be carriedout, the caregiver can cancel the request. In some embodiments, acanceled request communication is then transmitted to the medical deviceand displayed on the user interface of the device.

In some embodiments, a local override feature can be incorporated intothe system. If the medical device is unable to establish a connectionwith the caregiver device due to, for example, connections problems, therequest can be authorized locally by an authorized individual. Forexample, for a child at school the school nurse could enter a passwordor otherwise authenticate authority to locally authorize the delivery.In certain embodiments, the local override feature can also be employedwhen the caregiver device is connected to but does not respond by eitherauthorizing or cancelling the request within a predetermined period oftime.

In some embodiments, medical device 12 and/or caregiver device 302 cancommunicate with and receive data from one or more other devices orsensors, such as, for example, a blood glucose meter or continuousglucose monitor. In certain embodiments, the medical device can receivedata from the additional device and transmit the data to the caregiverdevice along with the request and other corresponding information.Alternatively, the caregiver device can communicate directly with theother device to receive data from the device.

In some embodiments, the caregiver device 302 can include software, suchas an application running on a smartphone, that can take into accountdata received from the medical device 12 and/or other devices, such as,for example, blood glucose level, insulin on board, and carbohydrates tobe consumed, to determine whether an operation should be performed withthe medical device, such as a bolus delivery, and make any necessarycalculations for such operations. In such embodiments, if the caregiverdevice 302 determines that an operation such as a bolus delivery shouldbe performed, the caregiver device can wirelessly transmit a command tothe medical device 12 to carry out the operation. In some embodiments,the medical device can automatically carry out the operation.Alternatively, an alert can appear on a user interface of the medicaldevice requiring a confirmation from the patient to carry out theoperation.

Referring now to FIG. 9, a system 400 according to embodiments of thepresent invention includes a medical device such as an insulin pump 12having a wireless connection 404 to a mobile phone 402 or other remoteconsumer electronic device, such as a smartphone, via, for example,Bluetooth®, Bluetooth® low energy, mobile, Wi-Fi or other communicationsprotocols or modalities. In some embodiments, the phone 402 can alsohave a wireless or wired connection 406 with a blood glucose meter 408or continuous glucose monitor (CGM) for receiving data from the bloodglucose meter 408 or CGM. Although the system 400 is described withrespect to a mobile phone, alternate types of remote consumer electronicdevices could be used in place of a phone as the device 402, including,for example, an electronic tablet or a laptop or desktop computer.Similarly, although described with respect to an insulin pump, themedical device 12 can be any other type of programmable medical devicecapable of wirelessly communication with a mobile phone 402 or otherdevice, including, for example, infusion pumps for infusing medicamentsother than insulin.

FIG. 10 depicts a flowchart of an operation sequence for using thesystem 400 of FIG. 9 to aid in administering therapy with the insulinpump 12. At step 502, the phone 402 establishes a connection 406 withthe blood glucose meter 408 or CGM. The phone 402 receives data from theblood glucose meter 408 or CGM such as a current or recent blood glucosevalue from a blood glucose meter 408 at step 504. The blood glucosevalue is then transmitted at step 506 to the infusion pump 12. Theinfusion pump 12 analyzes the data at step 508 as if the blood glucosevalue was entered in the pump's user interface or received directly fromthe blood glucose meter to determine if a bolus is needed. Generally,and as discussed in more detail in applications incorporated byreference herein, this calculation takes into account at least the bloodglucose value, a target blood glucose value or range, and any insulinremaining in the user's system that will subsequently affect the user'sblood glucose level, or insulin on board (IOB).

The correction bolus determination is communicated from the insulin pump12 to the phone 402 at step 510. Depending on the determination made bythe pump 12, the communication could include, for example, a generalrecommendation to take a correction bolus, a recommendation to take acorrection bolus of a specific amount calculated by the pump, or arecommendation to recheck blood glucose level after a period of time dueto IOB. If the recommendation is to take a correction bolus, thecommunication can refer the patient to the pump to deliver and/orcalculate the bolus amount. Alternatively, the phone 402 can includesoftware to make the determination regarding whether or not a bolus isneeded and, if so, calculate a specific amount for a correction bolus,provided that the phone has received the necessary information for sucha calculation either from the pump or through the phone user interface,such as IOB and a correction factor. In such an embodiment, the phone402 could then transmit that amount to the pump 12. When the user refersto the pump, the blood glucose information and/or the recommended boluscan be displayed. The bolus can then easily be delivered.

In some embodiments, a phone 402 can be used to aid in insulin pumptherapy without having a connection to a blood glucose meter. In suchembodiments, the phone 402 could receive from the pump 12 and optionallydisplay on the phone 12 any relevant variable from the pump, such asIOB. Other information relevant to pump operation, such as battery lifeand insulin remaining in the pump could also be stored and/or displayedon the phone 12. The phone could also display predicted future bloodglucose level(s) from a previously known blood glucose level eitherentered into the phone or received from the pump. Such predicted futureblood glucose levels could be determined based on, for example, bloodglucose/CGM trends, IOB and food/carbohydrates recently consumed. Ingeneral, any information that can be displayed on the pump 12 may bedisplayed on the phone 102 in any desired format or quantity. Forinstance, the phone 402 display can simply “mirror” that informationdisplayed or capable of being displayed on the pump 12 in exactly orsubstantially the same manner. Alternatively, any subset of data that isotherwise displayed or capable of being displayed on pump 12 may bedisplayed on the phone 402 as desired.

In certain embodiments, a phone 402 having a connection with a bloodglucose meter can also provide therapy assistance for manual delivery ofinsulin or other medicament, such as, e.g., glucagon, rather thantreatment with an insulin pump. For instance, the phone can utilizevalues received from the blood glucose meter to calculate, e.g., insulinbolus amounts for delivery with a non-connected device such as asyringe. In such embodiments, the phone 402 can receive insulin dose andcarbohydrate consumed values entered by the user and use those values incalculating the recommended dose.

A mobile phone such as a smartphone can also aid in logging andreviewing data associated with treatment using an insulin pump. Oneembodiment of a system 450 employing such an approach is shown in FIG.11. The system can include a mobile phone 402 such as a smartphone and amedical device 12 such as an insulin pump that are each capable ofcommunicating with a therapy management system 452 through a wireless orwired connection. Therapy management system 452 can operate on anydevice having memory for storing therapy parameters and a processor forexecuting commands, including, for example, a laptop or desktopcomputer, an electronic tablet or a mobile phone such as a smartphone.In one embodiment, the therapy management system 452 can be operated onthe same smartphone 402 used to capture data. Where the therapymanagement system 452 is operated on a separate device from the phone402, the medical device 12 can, but need not be, capable ofcommunication with the phone 402.

Advanced features of the smartphone 402 or other device can be used toobtain more detailed logging of meals for the therapy management systemthan simply a number of carbohydrates consumed as would be entered intoa pump or a therapy management system running on a computerindependently of a connection to the smartphone or other device. In oneembodiment, a user can take a picture of a meal that is about to beconsumed with the camera of the phone or, e.g., tablet computer. Inanother embodiment, the speaker of the phone or tablet computer can beemployed by the user to take voice notes on a meal or other event suchas exercise.

The picture, voice message, or other data can be downloaded from thephone 402 or tablet computer, etc. to the therapy management system 452through either a wireless or wired connection. In some embodiments, thedata is automatically analyzed for its content, such as by imagerecognition software or voice recognition software and the user ispresent with data, such as number of carbohydrates and other nutritionalinformation, that correlates to the downloaded picture, voice message,or other data, for storage in the therapy management system. In oneembodiment, software utilized by the therapy management systemundertakes this analysis. Alternatively, application software utilizedby the smartphone (software resident on the smartphone and/or on aremote computing device such as a server) can undertake the analysisprior to transmitting to the therapy management system 452. In suchembodiments, the therapy management system and/or the smartphone caninclude access to a nutritional lookup database that includescarbohydrates and other nutritional information for various foods. Inother embodiments, the data can be transmitted to the therapy system asan image, voice, etc. file for later manual review and manual entry ofcorresponding nutritional data. Each data file acquired with thesmartphone can have a time stamp that is also transmitted to the therapymanagement system to identify a time and date when it was acquired. Insome embodiments, the picture can be analyzed by a caregiver, such as aparent, either manually or utilizing a computer system for automaticanalysis, and the caregiver can then remotely authorize delivery of abolus or other action or actions as may be appropriate.

The therapy management system 452 can also be connected with the pump 12and therefore can also track operations carried out by the pump, such asdelivery of boluses. In some embodiments, the therapy management systemalso receives blood glucose values, either from the medical device orsmartphone or through a separate connection to a blood glucose meter.The therapy management system can therefore match meals consumed, pumpoperations, and/or blood glucose levels by the time stamps associatedwith those events. The system therefore permits a user or caregiver toretrospectively go back and look at previous therapy decisions that weremade and the subsequent effects in order to provide a guide for futuretherapy decisions.

Although generally described herein with respect to delivery of amedicament by a medical device, it should be understood that embodimentsof systems and methods described herein can be utilized with any type ofoperation that can be performed by a medical device. In addition,although generally described herein with respect to an infusion pump,and specifically an insulin pump, it should be understood that thesystem and method can be employed with any type of medical devicecapable of wireless communication with a smartphone, such as, forexample, infusion pumps for delivering medicaments other than insulin.In addition, although primarily described with respect to wirelesscommunications, various embodiments in which communications between thepump and caregiver device are facilitated through wired connections arealso contemplated.

With regard to the above detailed description, like reference numeralsused therein may refer to like elements that may have the same orsimilar dimensions, materials, and configurations. While particularforms of embodiments have been illustrated and described, it will beapparent that various modifications can be made without departing fromthe spirit and scope of the embodiments herein. Accordingly, it is notintended that the invention be limited by the forgoing detaileddescription.

The entirety of each patent, patent application, publication, anddocument referenced herein is hereby incorporated by reference. Citationof the above patents, patent applications, publications and documents isnot an admission that any of the foregoing is pertinent prior art, nordoes it constitute any admission as to the contents or date of thesedocuments.

Also incorporated herein by reference in their entirety are commonlyowned U.S. Pat. Nos. 8,287,495; 8,408,421 and 8,448,824; commonly ownedU.S. Patent Publication Nos. 2009/0287180; 2010/0008795; 2010/0071446;2010/0218586; 2012/0123230; 2013/0053816; 2013/0159456; and 2013/0306191commonly owned U.S. patent application Ser. Nos. 13/800,387; 13/800,453;13/800,595; 13/801,230; 13/801,274; 13/827,383; 13/827,707; 13/828,958;13/829,115; 13/832,531; 13/832,841; 13/837,661; 13/837,777; 13/838,084;13/838,617; 13/841,028; 13/841,432; 13/842,005; 13/842,990 and13/923,556; and commonly owned U.S. Provisional Application Ser. Nos.61/874,428 and 61/875,979.

Further incorporated by reference herein in their entirety are U.S. Pat.Nos. 8,601,465; 8,502,662; 8,452,953; 8,451,230; 8,449,523; 8,444,595;8,343,092; 8,285,328; 8,126,728; 8,117,481; 8,095,123; 7,999,674;7,819,843; 7,782,192; 7,109,878; 6,997,920; 6,979,326; 6,936,029;6,872,200; 6,813,519; 6,641,533; 6,554,798; 6,551,276; 6,295,506; and5,665,065.

Modifications may be made to the foregoing embodiments without departingfrom the basic aspects of the technology. Although the technology mayhave been described in substantial detail with reference to one or morespecific embodiments, changes may be made to the embodimentsspecifically disclosed in this application, yet these modifications andimprovements are within the scope and spirit of the technology. Thetechnology illustratively described herein may suitably be practiced inthe absence of any element(s) not specifically disclosed herein. Theterms and expressions which have been employed are used as terms ofdescription and not of limitation and use of such terms and expressionsdo not exclude any equivalents of the features shown and described orportions thereof and various modifications are possible within the scopeof the technology claimed. Although the present technology has beenspecifically disclosed by representative embodiments and optionalfeatures, modification and variation of the concepts herein disclosedmay be made, and such modifications and variations may be consideredwithin the scope of this technology.

1-20. (canceled)
 21. A method of providing medicament therapy to apatient with a medical infusion pump, comprising: determining anoperation to be performed by the medical infusion pump; transmittinginformation pertaining to the determined operation to a caregiverdevice; displaying an authorization request on the caregiver device toexecute the determined operation with the medical infusion pump;receiving authorization at the caregiver device in response to theauthorization request; transmitting an authorization command to executethe determined operation from the caregiver device to the medicalinfusion pump; and causing the medical infusion pump to execute thedetermined operation after receiving the authorization command.
 22. Themethod of claim 21, wherein the step of transmitting informationpertaining to the determined operation includes transmitting a number ofunits of insulin requested for a bolus delivery.
 23. The method of claim21, wherein the information pertaining to the determined operationincludes a glucose level of the patient.
 24. The method of claim 21,wherein the information pertaining to the determined operation includesnutritional information of a meal to be consumed by the patient.
 25. Themethod of claim 21, wherein the information pertaining to the determinedoperation includes an insulin on board of a patient.
 26. The method ofclaim 21, wherein the step of determining an operation to be performedincludes receiving input programming the operation from the patientthrough a user interface communicatively coupled to the medical infusionpump.
 27. The method of claim 21, wherein the step of determining anoperation to be performed includes automatically determining theoperation using a processor configured to control operations of themedical infusion pump.
 28. The method of claim 27, wherein the operationis automatically determined by the processor based on a glucose level ofthe patient.
 29. The method of claim 21, wherein the step oftransmitting information pertaining to the determined operation includestransmitting the information to the caregiver device by the medicalinfusion pump.
 30. The method of claim 21, wherein the step oftransmitting information pertaining to the determined operation includestransmitting the information to the caregiver device by a remoteconsumer electronic device of the patient.
 31. The method of claim 21,further comprising presenting an alert to the patient indicating thatthe determined operation has been authorized by the caregiver.
 32. Themethod of claim 31, wherein the step of presenting an alert to thepatient includes presenting the alert on a user interface of the medicalinfusion pump.
 33. The method of claim 31, wherein the step ofpresenting an alert to the patient includes presenting the alert on aremote consumer electronic device of the patient.
 34. The method ofclaim 31, wherein the step of causing the medical infusion pump toexecute the determined operation after receiving the authorizationcommand includes executing the determined operation after receiving aconfirmation from the patient in response to the alert.
 35. The methodof claim 21, wherein the step of causing the medical infusion pump toexecute the operation after receiving the authorization includesautomatically executing the operation after receiving the authorizationcommand.
 36. The method of claim 21, further comprising the step ofproviding a local override feature at the medical infusion pump, whereinthe local override feature enables authorization of the determinedoperation at the medical infusion pump if the medical infusion pump isunable to establish communication with the caregiver device.
 37. Themethod of claim 21, wherein the caregiver device is selected from thegroup consisting of a smartphone, an electronic tablet, a desktopcomputer, or a laptop computer.
 38. The method of claim 30, wherein theremote consumer electronic device of the patient is selected from agroup consisting of a smartphone, an electronic tablet, a desktopcomputer, or a laptop computer.
 39. The method of claim 21, wherein theinformation pertaining to the operation to be performed by the medicalinfusion pump includes a digital image of a meal.